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Diabetes MellitusNCT01892319

An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry

An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 93 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus. Read more about this study

Who is it for?
Any age, women only
What is being tested?
insulin detemir and other injectable antidiabetic treatment regimens
Type of treatment
Injection or infusion
How many people
2,446 participants
Where
93 sitesin 16 countries
Study dates
30 Sep 2013to 30 Sep 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Women with diabetes mellitus, who are pregnant and treated with Levemir® or other injectable antidiabetic treatment regimens, and who have not changed basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception will be included in the Diabetes Pregnancy Registry.

Inclusion Criteria: - Informed consent obtained before any data collection - Woman with a positive pregnancy test - Diabetes mellitus type 1 or 2, diagnosed prior to conception - Currently treated with Levemir® or other injectable antidiabetic treatment(s) - Unchanged basal insulin or other injectable antidiabetic treatment product (for those not treated with basal insulin) 4 weeks prior to and following conception Exclusion Criteria: - Women who have been pregnant for more than 16 weeks at baseline visit will be excluded from the study

Trial locations and contacts

93 sites in 16 countries.

93 sites in 16 countries

Malaysia12 sites

  • Novo Nordisk Investigational Site

    Alor Gajah, 78300

  • Novo Nordisk Investigational Site

    Alor Star, 05400

  • Novo Nordisk Investigational Site

    Alor Star, 05460

  • Novo Nordisk Investigational Site

    Batu Caves, 68100

  • Novo Nordisk Investigational Site

    Ipoh, 30450

  • Novo Nordisk Investigational Site

    Ipoh, 31400

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 52000

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 57000

  • Novo Nordisk Investigational Site

    Kuala Lumpur, 59100

  • Novo Nordisk Investigational Site

    Putrajaya, 62250

  • Novo Nordisk Investigational Site

    Seremban, 70300

  • Novo Nordisk Investigational Site

    Seremban, 70450

Other trials in Malaysia

Germany9 sites

  • Novo Nordisk Investigational Site

    Bramsche, 49565

  • Novo Nordisk Investigational Site

    Eisenach, 99817

  • Novo Nordisk Investigational Site

    Essen, 45136

  • Novo Nordisk Investigational Site

    Friedrichsthal, 66299

  • Novo Nordisk Investigational Site

    Ludwigshafen, 67059

  • Novo Nordisk Investigational Site

    Neuwied, 56564

  • Novo Nordisk Investigational Site

    Speyer, 67346

  • Novo Nordisk Investigational Site

    Stuttgart, 70184

  • Novo Nordisk Investigational Site

    Sulzbach-Rosenberg, 92237

Other trials in Germany

Italy9 sites

  • Novo Nordisk Investigational Site

    Livorno, 57124

  • Novo Nordisk Investigational Site

    Milan, 20132

  • Novo Nordisk Investigational Site

    Padova, 35143

  • Novo Nordisk Investigational Site

    Roma, 00189

  • Novo Nordisk Investigational Site

    Roma, 00195

  • Novo Nordisk Investigational Site

    Sant'Andrea Delle Fratte (PG), 06129

  • Novo Nordisk Investigational Site

    Torino, 10126

  • Novo Nordisk Investigational Site

    Trento, 38122

  • Novo Nordisk Investigational Site

    Verona, 37126

Other trials in Italy

United Kingdom8 sites

  • Novo Nordisk Investigational Site

    Bath, BA1 3NG

  • Novo Nordisk Investigational Site

    Belfast, BT12 6BA

  • Novo Nordisk Investigational Site

    Bristol, BS10 5NB

  • Novo Nordisk Investigational Site

    Devon, EX2 5DW

  • Novo Nordisk Investigational Site

    Glasgow, G31 2ER

  • Novo Nordisk Investigational Site

    Inverness, IV2 3JH

  • Novo Nordisk Investigational Site

    Southampton, SO16 5YA

  • Novo Nordisk Investigational Site

    Stevenage, SG1 4AB

Other trials in United Kingdom

France7 sites

  • Novo Nordisk Investigational Site

    Angers, 49000

  • Novo Nordisk Investigational Site

    Corbeil-Essonnes, 91106

  • Novo Nordisk Investigational Site

    Lille, 59037

  • Novo Nordisk Investigational Site

    Nîmes, 30006

  • Novo Nordisk Investigational Site

    Paris, 75014

  • Novo Nordisk Investigational Site

    Toulouse, 31054

  • Novo Nordisk Investigational Site

    Valenciennes, 59322

Other trials in France

Norway7 sites

  • Novo Nordisk Investigational Site

    Ålesund, 6026

  • Novo Nordisk Investigational Site

    Bergen, 5021

  • Novo Nordisk Investigational Site

    Gjøvik, NO-2819

  • Novo Nordisk Investigational Site

    Hamar, 2318

  • Novo Nordisk Investigational Site

    Lillehammer, 2609

  • Novo Nordisk Investigational Site

    Moss, 1535

  • Novo Nordisk Investigational Site

    Tønsberg, 3116

Other trials in Norway

Portugal7 sites

  • Novo Nordisk Investigational Site

    Almada, 2805-267

  • Novo Nordisk Investigational Site

    Amadora, 2720-276

  • Novo Nordisk Investigational Site

    Leiria, 2410-197

  • Novo Nordisk Investigational Site

    Lisbon, 1069-089

  • Novo Nordisk Investigational Site

    Lisbon, 1649-035

  • Novo Nordisk Investigational Site

    Porto, 4099-001

  • Novo Nordisk Investigational Site

    Porto, 4200-319

Other trials in Portugal

Poland6 sites

  • Novo Nordisk Investigational Site

    Legnica, 59-220

  • Novo Nordisk Investigational Site

    Lodz, 90-553

  • Novo Nordisk Investigational Site

    Lubin, 59-300

  • Novo Nordisk Investigational Site

    Poznan, 60-371

  • Novo Nordisk Investigational Site

    Poznan, 61-693

  • Novo Nordisk Investigational Site

    Szczecin, 70-376

Other trials in Poland

Romania6 sites

  • Novo Nordisk Investigational Site

    Bucharest, 020042

  • Novo Nordisk Investigational Site

    Bucharest, 020359

  • Novo Nordisk Investigational Site

    Bucharest, 020475

  • Novo Nordisk Investigational Site

    Bucharest, 022441

  • Novo Nordisk Investigational Site

    Galati, 800098

  • Novo Nordisk Investigational Site

    Timișoara, Timiș County, 300736

Other trials in Romania

Spain6 sites

  • Novo Nordisk Investigational Site

    Barcelona, 08025

  • Novo Nordisk Investigational Site

    Barcelona, 08036

  • Novo Nordisk Investigational Site

    Madrid, 28046

  • Novo Nordisk Investigational Site

    Málaga, 29006

  • Novo Nordisk Investigational Site

    Seville, 41014

  • Novo Nordisk Investigational Site

    Valencia, 46026

Other trials in Spain

Netherlands5 sites

  • Novo Nordisk Investigational Site

    Amsterdam, 1081 HV

  • Novo Nordisk Investigational Site

    Apeldoorn, 7334 DZ

  • Novo Nordisk Investigational Site

    Arnhem, 6815 AD

  • Novo Nordisk Investigational Site

    Eindhoven, 5631 BM

  • Novo Nordisk Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

Ireland4 sites

  • Novo Nordisk Investigational Site

    Castlebar

  • Novo Nordisk Investigational Site

    Co. Donegal

  • Novo Nordisk Investigational Site

    Dublin

  • Novo Nordisk Investigational Site

    Galway, H91 YR71

Other trials in Ireland

Finland3 sites

  • Novo Nordisk Investigational Site

    Pori, 28500

  • Novo Nordisk Investigational Site

    Tampere, 33521

  • Novo Nordisk Investigational Site

    Turku, 20520

Other trials in Finland

Greece2 sites

  • Novo Nordisk Investigational Site

    Athens, GR-11528

  • Novo Nordisk Investigational Site

    Nea Efkarpia - Thessaloniki, GR-56403

Other trials in Greece

Croatia1 site

  • Novo Nordisk Investigational Site

    Zagreb, 10000

Other trials in Croatia

Israel1 site

  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

Other trials in Israel

About this study

Official title: An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Levemir® (Insulin Detemir) in Pregnant Women With Diabetes Mellitus

This study is conducted in Europe and Asia. The purpose of the study (Diabetes Pregnancy Registry) is to evaluate the safety of treatment with insulin detemir in pregnant women with diabetes mellitus.

Being tested
insulin detemir, other injectable antidiabetic treatment regimens
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • insulin detemirDrug

    Patients will be treated according to routine clinical practice at the discretion of the treating physician

  • other injectable antidiabetic treatment regimensDrug

    Patients will be treated according to routine clinical practice at the discretion of the treating physician

Study groups in NCT01892319
Study groupRoleWhat they receive
All patientsNot described
Receives: Drug: insulin detemir; Drug: other injectable antidiabetic treatment regimens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death

    Measured: Assessed up to 4 weeks after delivery

Secondary outcomes (9)

  1. Incidence of major hypoglycaemia

    Measured: During pregnancy

  2. Proportion of pregnancies complicated by pre-eclampsia

    Measured: During pregnancy

  3. Proportion of pregnancies resulting in perinatal death

    Measured: Assessed 1 week after delivery

  4. Proportion of pregnancies resulting in neonatal death

    Measured: Assessed 4 weeks after delivery

  5. Proportion of pregnancies resulting in spontaneous abortion

    Measured: Assessed at pregnancy termination

  6. Proportion of pregnancies resulting in pre-term delivery

    Measured: Assessed at delivery

  7. Height

    Measured: At the age of 1 year

  8. Weight

    Measured: At the age of 1 year

  9. Proportion with changes (progression/regression) of major congenital malformations

    Measured: At the age of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2013 (estimated)
  2. Study start30 Sep 2013
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01892319
Sponsor's protocol ID
NN304-4016
Other IDs
U1111-1132-9442, ENCEPP/SDPP/4137
Status last verified
Nov 2019
First submitted
27 Jun 2013
Last updated
19 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Mathiesen ER, Andersen H, Kring SI, Damm P. Design and rationale of a large, international, prospective cohort study to evaluate the occurrence of malformations and perinatal/neonatal death using insulin detemir in pregnant women with diabetes in comparison with other long-acting insulins. BMC Pregnancy Childbirth. 2017 Jan 18;17(1):38. doi: 10.1186/s12884-016-1177-4.

    PubMed 28100192

  • Thorius IH, Petersen J, Husemoen LLN, Alibegovic AC, Gall MA, Damm P, Mathiesen ER. Glycemic Control and Risk of Congenital Malformations in Women With Type 1 Diabetes. Obstet Gynecol. 2024 Nov 1;144(5):725-732. doi: 10.1097/AOG.0000000000005722. Epub 2024 Sep 5.

    PubMed 39236320

  • Thorius IH, Husemoen LLN, Nordsborg RB, Alibegovic AC, Gall MA, Petersen J, Damm P, Mathiesen ER. Fetal Overgrowth and Preterm Delivery in Women With Type 1 Diabetes Using Insulin Pumps or Multiple Daily Injections: A Post Hoc Analysis of the EVOLVE Study Cohort. Diabetes Care. 2024 Mar 1;47(3):384-392. doi: 10.2337/dc23-1281.

    PubMed 38128075

  • Mathiesen ER, Ali N, Alibegovic AC, Anastasiou E, Cypryk K, de Valk H, Dores J, Dunne F, Gall MA, Garcia SD, Hanaire HP, Husemoen LLN, Ivanisevic M, Kempe HP, McCance DR, Damm P. Risk of Major Congenital Malformations or Perinatal or Neonatal Death With Insulin Detemir Versus Other Basal Insulins in Pregnant Women With Preexisting Diabetes: The Real-World EVOLVE Study. Diabetes Care. 2021 Sep;44(9):2069-2077. doi: 10.2337/dc21-0472. Epub 2021 Jul 30.

    PubMed 34330786

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 93 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in Malaysia, Germany, Italy, United Kingdom, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of pregnancies (Levemir® treatment), compared to pregnancies (other basal insulin treatment regimens), resulting in none of the following events: Major congenital malformations, Perinatal death, Neonatal death (time frame: Assessed up to 4 weeks after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01892319, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.

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